Therapy efficacy, compliance and long-term outcome of Auto-bilevel therapy compared to continuous positive airway pressure (CPAP) therapy in obstructive sleep apnoea (OSA) patients

ISRCTN	ISRCTN53816305
DOI	https://doi.org/10.1186/ISRCTN53816305
Protocol serial number	EAME05AUTOBILEVEL01
Sponsor	Respironics International, Inc. (France)
Funder	Respironics International, Inc. (France)

Submission date: 29/10/2008
Registration date: 11/12/2008
Last edited: 20/11/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ingo Fietze
Scientific

Center of Sleep Medicine
Department of Internal Medicine
Charité-Universitätsmedizin Berlin, CCM
Luisenstr. 13
Berlin
10117
Germany

Email	ingo.fietze@charite.de

Study information

Primary study design	Interventional
Study design	Controlled, double-blind randomised study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	AUTOBILEVEL
Study objectives	We hypothesised that auto-bilevel therapy would be equivalant to fixed continuous positive airway pressure (CPAP) therapy on parameters of objective and subjective compliance and therapeutic effectiveness in patients with moderate to severe obstructive sleep apnoea.
Ethics approval(s)	Ethikkommission of Charite Campus-Mitte gave approval on the 1st March 2006 (ref: EA1/044/08)
Health condition(s) or problem(s) studied	Obstructive sleep apnoea
Intervention	After a CPAP titration night patients will be randomised to three months of either BiPAP auto with Biflex or fixed level CPAP. Patients will be followed up at 1, 4, 8 and 12 weeks.
Intervention type	Other
Primary outcome measure(s)	Treatment and therapeutic efficacy will be measured by polysomnography (PSG) at diagnosis, titration and 12 weeks (end of study).
Key secondary outcome measure(s)	1. Objective compliance measured by device memory download at one week and the end of the study 2. Subjective compliance and parameters of wellbeing measured at baseline, 4, 8, 12 weeks 3. Epworth Sleepiness Scale measured at baseline (after diagnostic PSG and after titration PSG), 4, 8 and 12 weeks 4. Pittsburgh Sleep Quality Index measured at baseline (after diagnostic PSG only), 4, 8 and 12 weeks 5. Functional Outcomes of Sleep Questionnaire measured at baseline (after diagnostic PSG only), 4, 8 and 12 weeks 6. Calgary Sleep Apnoea Quality of Life Index measured at baseline (after diagnostic PSG only), 4, 8 and 12 weeks 7. 12-item Short Form (SF-12) measured at baseline (after diagnostic PSG only), 4, 8 and 12 weeks 8. Visual Analogue Scale measured in the morning and evening at baseline (after diagnostic PSG and after titration PSG), 4, 8 and 12 weeks 9. Treatment Satisfaction Visual Analogue Scale measured at baseline (after titration PSG only), 4, 8 and 12 weeks 10. Treatment Comfort Visual Analogue Scale measured at baseline (after titration PSG only), 4, 8 and 12 weeks 11. Mask/Interface Comfort Visual Analogue Scale measured at baseline (after titration PSG only), 4, 8 and 12 weeks
Completion date	09/06/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	32
Key inclusion criteria	1. Apnoea/Hypopnoea Index (AHI) greater than 15/h 2. Aged greater than or equal to 21 years and less than or equal to 65 years, either sex 3. Body mass index (BMI) less than 40 kg/m^2 4. Able to follow the study protocol 5. Successful CPAP titration
Key exclusion criteria	1. Drug abuse 2. Intake of central relevant drugs, sedatives, or other drugs with impairment of sleep 3. Alcohol abuse; consume more than 30 g/d 4. Participation in other clinical-pharmacological studies up to 4 weeks prior of study begin 5. Psychiatric or neurological diseases resulting in impairment of sleep, therapy or compliance 6. Thyroidal dysfunction 7. Chronic pain syndromes 8. Acute cardiac, pulmonary, and other internal diseases 9. Chronic cardiac, pulmonary and other internal diseases resulting in impairment of sleep 10. Central sleep-related breathing disorders or other disorders resulting in hypoventilation 11. Periodic leg movements (PLM)/restless legs syndrome (RLS) 12. Previous exposure to either CPAP or bilevel therapy
Date of first enrolment	05/06/2006
Date of final enrolment	09/06/2007

Locations

Countries of recruitment

Germany

Study participating centre

Center of Sleep Medicine

Berlin
10117
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes